Infection prevention

Mölnlycke® Health Care Applauds the Food & Drug Administration For Its Decision to Ban Powdered Medical Gloves

By: Mölnlycke Health Care, January 7 2017Posted in: Infection prevention

Mölnlycke Health Care applauds the Food & Drug Admnistration for its final rule to ban powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove. The FDA stated that because powdered gloves present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling, the FDA was consequently banning those devices.1

Mölnlycke Health Care, the manufacturer of Biogel® surgical gloves was the world’s first powder-free surgical glove manufacturer. With its release of the proprietary Biogel coating 30 years ago, it made donning surgical gloves possible without glove powder. Due to the known clinical concerns that glove powder poses for both health care workers and patients, the Biogel product line has always been exclusively powder-free. Since their introduction, Biogel gloves have continued to set the industry standard for surgical glove quality offering a wide range of sterile surgeon’s glove options for various clinical applications.

”The FDA’s ruling to ban powdered gloves is a significant positive step forward to addressing safety concerns of patients and health care workers,” said Shri Parikh, Vice President of Surgical Sales and Marketing for Mölnlycke Health Care. ”Given that the FDA has only banned one other medical device in recent history, the elimination of powdered medical gloves sends a strong statement regarding its risks.” The FDA stated that despite posted comments requesting a 90 day to 18 month transition period, the FDA decided to make the ban effective January 18, 2017 because it determined an extension was not in the best interest of human health.

 

 

 

Notes for Editors

About Mölnlycke Health Care
Mölnlycke Health Care is a world-leading provider of single-use surgical and wound care products for customers, healthcare professionals and patients. We develop and bring to market innovative wound care and surgical products for use in a range of settings – from prevention through acute care to homecare. Our solutions provide value for money, supported by clinical and health economic evidence.

For media inquiries:
Deborah G. Bolding, Communications
Mölnlycke Health Care
debbie.bolding@molnlycke.com

 

 

 

 

1 “Banned Devices; Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Glove; Final Rule.” 81 FR 91722 (19 December 2016), pp. 91722-91731

Share this

More from the same category

Reusable staff clothes carry harmful...

Mölnlycke Health Care, Surgical division comments on the paper ”Nursing...

Mölnlycke voices support for WHO’s call-to-action...

Mölnlycke Health Care supports the goals of the recently-announced World...

Introducing Biogel® PI Micro

Expanding the Mölnlycke Health Care surgical glove range, the Biogel® PI...

Introducing Biogel PI OrthoPro

Reduced Risk for the Orthopedica Team: Thicker - Biogel® PI OrthoPro®...

Molnlycke Health Care Commendes FDA...

Mölnlycke Health Care commends the Food & Drug Admnistration for its proposed...

Introducing Biogel® PI Micro Indicator®...

Mölnlycke Health Care is enhancing its Biogel® PI Micro range to offer...

Mölnlycke® Health Care posts docket...

Mölnlycke® Health Care confirmed its support of the Food & Drug Admnistration’s...